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Acceptance of Human Papillomavirus Vaccination in Postpartum Women (HPV Acceptance)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730704
First Posted: August 8, 2008
Last Update Posted: November 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jason D. Wright, Columbia University
  Purpose
Worldwide cervical cancer remains a major cause mortality among women. It is estimated that each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die from the disease. While the implementation of widespread screening programs has reduced the burden of cervical cancer, a large percentage of the population still remains unscreened or is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary precursor for the development of cervical cancer. The first vaccine to prevent HPV was recently approved by the Food and Drug Administration and is now available at doctors offices. Despite the availability of a safe and effective means for the prevention of cervical cancer, widespread implementation of vaccination has been extremely difficult. Several potential issues have limited the development of widespread HPV vaccination programs, including cultural and religious beliefs, and limitations in the practicality of administering the vaccine. The overall goals of our work are to improve access to preventive strategies for cervical cancer. In this proposal we will examine the strategy of HPV vaccination for women who have just given birth. We believe that HPV vaccination of these women will be associated with a high level of patient satisfaction and acceptance. If successful, this strategy could play a major role in advancing the acceptance and implementation of HPV vaccination in the United States.

Condition
Human Papilloma Virus HPV Post Partum

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acceptance of Human Papillomavirus Vaccination in Postpartum Women

Resource links provided by NLM:


Further study details as provided by Jason D. Wright, Columbia University:

Enrollment: 150
Study Start Date: May 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Primary Objective

1. To estimate compliance with the HPV vaccine series when initiated in postpartum women.

Secondary Objectives

  1. To determine patient acceptance and satisfaction with HPV vaccination administered in the postpartum period.
  2. To determine predictors of compliance with the HPV vaccination series.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, aged 18-26, hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.
Criteria

Inclusion Criteria:

  • Age 18-26 years.
  • Patients hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.
  • Patients who delivered a singleton fetus or multiple gestations are eligible for participation.
  • Patients may have delivered at gestational ages 32-44 weeks.
  • Patients must have signed informed consent.
  • Patients must meet pre-entry criteria.
  • Patients who are breast feeding are eligible for participation.
  • Patients must have an obstetrician whom they have seen for obstetric care and plan to follow-up with in the postpartum period.

Exclusion Criteria:

  • Age < 18 or > 26 years.
  • Patients with hemophilia, other bleeding disorders or thrombocytopenia (platelets < 100,000/ul).
  • Patients receiving active anticoagulant therapy with warfarin, heparin or low molecular weight heparin.
  • Pregnancy or planning pregnancy within the next 6 months.
  • Ongoing bacteremia, endomyometritis or other serious febrile illness.
  • Hypersensitivity to yeast, aluminum or other vaccine components.
  • Prior vaccination with a prophylactic HPV vaccine (single or multiple doses).
  • Patients who delivered a non-viable infant or an infant with severe congenital malformations.
  • Patients who do not plan on following up postpartum with their local obstetrician or maternal fetal medicine specialist.
  • Patients who are unwilling to receive subsequent doses of the HPV vaccine.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730704


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jason Wright, MD Columbia University
  More Information

Publications:
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108.
Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Muñoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9.
Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007 Sep 8;370(9590):890-907. Review.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27.
Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43.
Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702.
Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8.
Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU; Proof of Principle Study Investigators. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002 Nov 21;347(21):1645-51.
Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.
Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J Low Genit Tract Dis. 2004 Jul;8(3):188-94.
Lazcano-Ponce E, Rivera L, Arillo-Santillán E, Salmerón J, Hernández-Avila M, Muñoz N. Acceptability of a human papillomavirus (HPV) trial vaccine among mothers of adolescents in Cuernavaca, Mexico. Arch Med Res. 2001 May-Jun;32(3):243-7.
Slomovitz BM, Sun CC, Frumovitz M, Soliman PT, Schmeler KM, Pearson HC, Berenson A, Ramirez PT, Lu KH, Bodurka DC. Are women ready for the HPV vaccine? Gynecol Oncol. 2006 Oct;103(1):151-4. Epub 2006 Mar 21.
Taylor JA, Darden PM, Brooks DA, Hendricks JW, Wasserman RC, Bocian AB; Pediatric Research in Office Settings; National Medical Association. Association between parents' preferences and perceptions of barriers to vaccination and the immunization status of their children: a study from Pediatric Research in Office Settings and the National Medical Association. Pediatrics. 2002 Dec;110(6):1110-6.
Tissot AM, Zimet GD, Rosenthal SL, Bernstein DI, Wetzel C, Kahn JA. Effective strategies for HPV vaccine delivery: the views of pediatricians. J Adolesc Health. 2007 Aug;41(2):119-25.
Kahn JA, Zimet GD, Bernstein DI, Riedesel JM, Lan D, Huang B, Rosenthal SL. Pediatricians' intention to administer human papillomavirus vaccine: the role of practice characteristics, knowledge, and attitudes. J Adolesc Health. 2005 Dec;37(6):502-10.
Daley MF, Liddon N, Crane LA, Beaty BL, Barrow J, Babbel C, Markowitz LE, Dunne EF, Stokley S, Dickinson LM, Berman S, Kempe A. A national survey of pediatrician knowledge and attitudes regarding human papillomavirus vaccination. Pediatrics. 2006 Dec;118(6):2280-9.

Responsible Party: Jason D. Wright, Assistant Professor of Gynecologic Oncology, Columbia University
ClinicalTrials.gov Identifier: NCT00730704     History of Changes
Other Study ID Numbers: AAAD1877
First Submitted: August 4, 2008
First Posted: August 8, 2008
Last Update Posted: November 5, 2012
Last Verified: November 2012

Keywords provided by Jason D. Wright, Columbia University:
Human Papilloma Virus vaccines
HPV
Gardasil
Post partum

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms


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